GSP INSTRUMENT AND GSP NEONATAL HTSH KIT— 510(k) K090846
Substantially EquivalentPerkinelmer, Inc.
FDA 510(k) clearance K090846 for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT, Substantially Equivalent on 2009-09-03. Applicant: Perkinelmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Perkinelmer, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Perkinelmer, Inc.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090846
K-number listed on FDA's recall record- Z-1107-2017 — Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
- Z-2121-2012 — Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090846.
Data sourced from openFDA. This site is unofficial and independent of the FDA.